Clinical Experience

Used in over 50,000 patients worldwide,* MitraClip® is a well-established therapy

In clinical studies, more than 1200 patients in the United States have been treated with MitraClip® therapy, with 1-year follow-up in over 900 patients.1 The MitraClip® device received CE Mark approval in Europe in 2008 and U.S. FDA approval in 2013.

Real-world data from the STS/ACC TVT™ Registry show favorable results; and the STS/ACC TVT™ Registry continues to grow, with more than 200 participating centers with data for over 4000 patients.2,3

Learn about the various clinical studies for MitraClip® therapy by clicking on or tapping the plus (+) symbols on the timeline below.

2003 – 2006

EVEREST I

(55 Patients Enrolled)

The EVEREST I trial was a prospective, multicenter registry trial designed to evaluate the preliminary safety and effectiveness of the MitraClip® device in the treatment of moderate-to-severe (3+) or severe (4+) chronic MR using up to 2 MitraClip® devices per patient.1

Study Highlights1

Enrolled 55 patients at 11 U.S. sites

Follow-up at 30 days, 6, 18, and 24 months, and 3, 4, and 5 years

Primary Endpoint1

Major Adverse Event rate through 30 days

2005 – 2008

EVEREST II RCT

(279 Patients Enrolled)

The EVEREST II RCT was a prospective, blinded, randomized, controlled, multicenter study comparing the safety and effectiveness of the MitraClip® procedure to mitral valve surgery. This was a landmark trial, being the first randomized trial to compare a transcatheter intervention for the reduction of MR to standard-of-care mitral valve surgery.1

Study Highlights1

Patients with significant symptomatic mitral regurgitation (MR ≥ 3+) of either Functional MR or Degenerative MR etiology who were non–high-risk candidates indicated for and who could undergo mitral valve surgery

Patients were evaluated at baseline, discharge, 30 days, 6, 12, 18, and 24 months, and annually thereafter through 5 years

Primary Endpoints1

Safety: Major Adverse Event rate through 30 days or time of discharge, whichever is greater

Secondary Effectiveness Endpoints1

Measures of LV function

SF-36 quality of life

NYHA Functional Class

2007 – 2008

EVEREST II HRRS

(78 Patients Enrolled)

The EVEREST II High Risk Registry Study was a prospective, multicenter registry designed to be adjunctive to the EVEREST II RCT and to evaluate the safety and effectiveness of the MitraClip® device in the treatment of high-surgical-risk (≥ 12%) patients with moderate-to-severe (3+) or severe (4+) chronic MR using up to 2 MitraClip® devices per patient.1

Study Highlights1

Enrolled 78 patients at 27 North American sites

Follow-up at 30 days, 6, 12, 18, and 24 months, and 3, 4, and 5 years

Safety Endpoints1

Primary: Procedural mortality at 30 days

Secondary: Major Adverse Event rate at 30 days and 12 months

Major Secondary Endpoints1

Measures of LV function

SF-36 quality of life

NYHA Functional Class

CHF hospitalizations

2009 – 2014

REALISM High Risk

(899 Patients Enrolled)

REALISM HR was a single-arm, self-controlled adjunctive study enrolling the same patient population as the EVEREST II HRRS and designed to continue to collect safety and effectiveness data and allow patients continued access to the MitraClip® device during review of the Premarket Approval (PMA) application.1

2009 – 2012

ACCESS Europe

(567 Commercial Patients Enrolled)

ACCESS Europe was a prospective, multicenter, nonrandomized postapproval study of MitraClip® therapy. This postmarket observational study of the MitraClip system was conducted to gather information regarding health economics and clinical care in Europe.

Study Highlights

Mean logistic European System for Cardiac Operative Risk Evaluation at baseline was 23.0 ± 18.3

84.9% of patients were in NYHA Functional Class III or IV, and 52.7% of patients had an ejection fraction ≤40%

Primary Endpoints

Minnesota Living with Heart Failure Questionnaire 12-month follow-up

6-minute walk distance test at 12 months

2013 – present

COAPT Trial

(Currently Enrolling)

The COAPT Trial is a prospective, randomized, parallel-controlled clinical evaluation of the MitraClip® device for the treatment of clinically significant functional MR in symptomatic heart failure patients.

This multicenter study will examine the safety and efficacy of the MitraClip® device used in addition to guideline-directed medical therapy for functional MR and heart failure (device group) compared to treatment with guideline-directed medical therapy alone (control group).

The COAPT Trial is currently enrolling patients. To learn more about the trial and patient eligibility, please visit COAPTtrial.com.

Swipe to explore the timeline.

COAPT Trial: Currently enrolling patients with functional MR

The COAPT Trial is a prospective, randomized, parallel-controlled clinical evaluation of the MitraClip® device for the treatment of clinically significant functional MR in symptomatic heart failure patients. This multicenter study will examine the safety and efficacy of the MitraClip® device used in addition to standard care for functional MR and heart failure (device group), compared to treatment with guideline-directed medical therapy (control group).

Improved reimbursement year after year

Recent changes in reimbursement improve the financial viability of MitraClip® therapy. The most recent FY 2017 DRG reassignment—to MS-DRGs 228-229—greatly improves Medicare reimbursement. Furthermore, continued support from CMS indicates they recognize the value of the MitraClip® NT technology and the procedure.†

MitraClip&reg NT Clip Delivery System

INDICATION FOR USE
The MitraClip&reg NT Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

CONTRAINDICATIONS
The MitraClip&reg NT Clip Delivery System is contraindicated in DMR patients with the following conditions:

DO NOT use MitraClip&reg NT outside of the labeled indication. Treatment of non-prohibitive risk DMR patients should be conducted in accordance with standard hospital practices for surgical repair and replacement.

MitraClip&reg NT is intended to reduce mitral regurgitation. The MitraClip&reg NT procedure is recommended to be performed when an experienced heart team has determined that reduction of MR to ≤2+ is reasonably expected following the MitraClip&reg NT. If MR reduction to ≤2+ is not achieved, the benefits of reduced symptoms and hospitalizations, improved quality of life, and reverse LV remodeling expected from MitraClip&reg NT may not occur.

The MitraClip&reg NT Device should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g., transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.

Read all instructions carefully. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip&reg NT System to avoid user injury.

Use of the MitraClip&reg NT should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.

The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and/or reuse may result in infections, malfunction of the device or other serious injury or death.

PRECAUTIONS

Patient Selection:

Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:

Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc.

Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF <20% or an LVESD >60mm. MitraClip&reg NT should be used only when criteria for clip suitability for DMR have been met.

The major clinical benefits of MitraClip&reg NT are reduction of MR to ≤2+ resulting in reduced hospitalizations, improved quality of life, reverse LV remodeling and symptomatic relief in patients who have no other therapeutic option. No mortality benefit following MitraClip&reg NT therapy has been demonstrated.

The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.

The heart team may determine an in-person surgical consult is needed to complete the assessment of prohibitive risk. The experienced mitral valve surgeon and heart team should take into account the outcome of this surgical consult when making the final determination of patient risk status.

For reasonable assurance of device effectiveness, pre-procedural evaluation of the mitral valve and underlying pathologic anatomy and procedural echocardiographic assessment are essential.

Note the “Use by” date specified on the package.

Inspect all product prior to use. DO NOT use if the package is opened or damaged, or if product is damaged.

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